Identity
- Trade Name
- ihtEvolve 2.5(SC)/2,75(NC)x10mm EUDAMED
- Device Name
- PTCA Dilatation Catheter EUDAMED
- Model / Reference
- 0067251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097932707 EUDAMED
- Basic UDI-DI
- B-08428097932707 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
ihtEvolve 2.5(SC)/2, 75(NC)x10mm by Iberhospitex, S.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08428097932707 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED 2a1921ca-2b7a-407a-a506-0d8e1d86d680 61 fields · synced Jul 29, 2026